Annals of Oncology Advance Access originally published online on June 24, 2009
Annals of Oncology 2009 20(11):1813-1817; doi:10.1093/annonc/mdp202
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breast cancer |
Gefitinib treatment in hormone-resistant and hormone receptor-negative advanced breast cancer
1 Department of Medical Oncology, Western and Royal Melbourne Hospitals, Parkville, Victoria
2 Department of Haematology and Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria
3 National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia
4 Regional Cancer and Blood Centre, Auckland City Hospital, Auckland, New Zealand
5 Department of Medical Oncology, Flinders Medical Centre, Bedford Park, South Australia
6 Mount Medical Centre, Perth, Western Australia
7 Department of Oncology, St Vincent's Hospital, Melbourne, Victoria
8 Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Newcastle, New South Wales
9 University of Newcastle, Newcastle, New South Wales
10 Department of Surgical Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia
* Correspondence to: Dr M. Green, Department of Medical Oncology, Western and Royal Melbourne Hospitals, C/- Post Office Royal Melbourne Hospital, Parkville Victoria 3050, Australia. Tel: +613-9342-7560; Fax: +613-9347-7508; E-mail: michael.green{at}mh.org.au
Background: Acquired and de novo endocrine resistance in breast cancer (BC) may be associated with overexpression of epidermal growth factor receptor (EGFR). Gefinitib is an orally active selective EGFR inhibitor which might benefit advanced breast cancer (ABC) patients either with acquired hormone resistance or with hormone receptor (HR)-negative tumors.
Patients and methods: A two-arm multicenter phase II trial of oral gefitinib 500 mg/day was planned in two groups of 45 patients with ABC for whom chemotherapy was not currently indicated. Group 1 had hormone-resistant BC defined as HR-positive BC with progression after treatment with tamoxifen and an aromatase inhibitor. Group 2 had HR-negative BC. Tumor response was assessed every 8 weeks. The primary end point was the clinical benefit rate (CBR).
Results: Forty patients with hormone-resistant BC had a CBR of 0%. Two of 25 HR-negative BC patients showed stable disease (less than a 50% reduction and less than a 25% increase in the sum of the products of two perpendicular diameters of all measured lesions and the appearance of no new lesions) at 24 weeks resulting in a CBR of 7.7% (95% CI 0.9% to 25.1%). Enrollment ceased due to the low CBR. Toxicity resulted in treatment interruption (46%), dose reduction (20%) and withdrawal (11%) of patients.
Conclusion: At a dose of 500 mg/day, gefitinib monotherapy resulted in a low CBR and no tumor response was identified.
Key words: advanced breast cancer, gefitinib, phase II trial
Received for publication February 25, 2009. Accepted for publication March 5, 2009.
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